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Skills

  • Supervision
  • Relationship development
  • End-to-End Trial Oversight
  • Case management
  • Cross-functional team management
  • CAPA (Corrective and Preventative Action) implementation
  • Budgets
  • Staff management
  • Process improvement
  • Chronic disease management

Work Experiences

  • Was in charge of keeping track of patient records as well as ensuring patient privacy and clinical compliance.
  • Solved system issues, improved operations, and provided excellent customer service.
  • Assessed the progress of patients and their responses to various treatments.
  • Assessed the quality of standard clinical trials.
  • Achieved results in under one year.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Automated processes for clinical quality monitoring.
  • Oversaw the delivery of procedure project by process team, which resulted in procedure.
  • Looked for industry trends on social media and through online sources.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.

Summaries

  • Costs were consistently reduced while profits were increased.
  • Achieved zero or reduced citation rates.
  • Consistently delivers high-quality clinical oversight by collaborating with multidisciplinary teams, achieving 48% reduction in non-compliance and protocol deviations.
  • Achieved savings of $8.
  • Consistently improved data accuracy.
  • Clear understanding of quality assurance and vendor management as well as quality assurance training.
  • Patient consultations, medication and treatment administration, and patient records maintenance are all skills she possesses.
  • Achieved significant improvements in clinical data accuracy.
  • Addressed deviation root causes.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.

Accomplishments

  • Advised on the regulatory impact of program changes in study design, preventing costly delays in 16 international clinical trials.
  • Conducted root cause analysis that led to the identification of key process inefficiencies, reducing clinical trial deviations by 31%.
  • Introduced lean-process improvements in clinical trial management procedures, reducing operational timelines by 37%.
  • Designed and implemented a CAPA system that achieved a 66% reduction in clinical deviations in 2020.
  • Facilitated cross-functional workshops on FDA regulatory changes, ensuring 3 departments were fully trained and compliant within one year.
  • Drove quality improvement initiatives across clinical operations, resulting in a process of significant audit findings.
  • Collaborated with cross-functional teams to achieve a 84% improvement in patient safety documentation, leading to smoother regulatory submissions.
  • Oversaw the successful completion of 17 clinical audits by external authorities, with a 60% pass rate for compliance excellence.
  • Streamlined communications between clinical teams and executive leadership, resulting in more effective project decision-making processes and cost savings of 48%.
  • Drafted new SOPs for clinical monitoring, leading to a 65% decrease in audit findings in international trials.

Affiliations

  • Society of Women Engineers
  • Association of Information Technology Professionals
  • International Society of Pharmacovigilance (ISoP)
  • Pharmaceutical Quality Group (PQG)
  • Association of Clinical Research Professionals (ACRP)
  • Society of Human Resource Management
  • Society for Translational Oncology (STO)
  • European Society for Clinical Research (ESCR)
  • Alliance for Clinical Research Excellence and Safety (ACRES)
  • Society of Quality Management (SQM)

Certifications

  • Certified Regulatory Compliance Manager (CRCM) - procedure
  • Project Management Professional (PMP)
  • Good Clinical Practice (GCP) Certification - program
  • Clinical Trial Management Software (CTMS) Compliance Certification - Adobe Creative Suite
  • Certified Public Accountant (CPA)
  • Pharmacovigilance Quality Assurance Certification - Columbus
  • ICH-GCP Certified Professional Auditor (CGPA) - Atlanta
  • Data Collection Accuracy and Clinical Trial Documentation Certification - Northwind
  • Salesforce
  • Certified Quality Auditor (CQA) - initiative

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